Zyzhan guide: Pharmaceutical machinery isolation is the use of special equipment, transition facilities and other technical means to isolate people from pharmaceutical materials, production environment and other processes, and through these special devices, transition facilities and other means to transition operations. For example, glove operated, isolation bins, robotic devices, transition pipelines, and other automated devices.
Why is isolation technology a trend in the future development of pharmaceutical machinery? It is well known that the production of pharmaceuticals is controlled by two parts of insoluble particles and microorganisms such as dust. Among them, the control of insoluble particulate pollution is one of the most difficult indicators to control in aseptic production. The source of insoluble particulates has four aspects in the production process, namely utility system, operating system, process material system and equipment or appliance system. .
In order to ensure the control indicators of insoluble particulate pollution, it is necessary to strictly control all aspects, of which the operating system involves human factors. General clean room Under normal circumstances, the biggest source of pollution in the room is still human. Often more concerned about the amount of bacteria in the human body, the microorganisms in the indoor air are mainly attached to the particles and droplets sprayed from the nasal cavity and mouth of the human body. Therefore, people are the main factor in the amount of dust generated and the amount of bacteria emitted, so the number of people entering the clean room should be strictly controlled. In the appendix to the new European GMP amendment, it is still considered that “the use of isolation techniques that limit the movement of personnel in production areas can effectively reduce the risk of bacterial contamination in the production of sterile pharmaceutical products.â€
In addition, while considering the pollution in the clean area, we must also consider: (1) The fresh air volume of the clean room must be 40m3/h per person. If more people enter, the air conditioning system will become larger and the power will be It will be wasted; (2) At present, the domestic clean system verification is still limited to the static process, and there is still a distance from the cGMP requirements dynamic process. The main factor of the dynamic process is the personnel dynamics. It can be seen that the key to the clean production of pharmaceuticals is humans, so that the process of pharmaceutical machinery is in great need of isolation or unmanned development.
There is now a trend to reduce operator exposure limits (from 10μg/m3 to less than 1μg/m3) in pharmaceutical production. The ideal assembly line should be a closed system with on-site (in-place) cleaning or field cleaning. Direct exposure of the operator during the cleaning and maintenance process can be avoided. The root of this statement is the relative isolation between people and the production of drugs.
In addition, the isolation technology of the pharmaceutical process also plays a safety role while ensuring the production process. The implementation of pharmaceutical machinery isolation can use isolation to achieve human protection. Because the pharmaceutical process is like the chemical industry, its production process involves toxic and harmful, susceptibility and other dangerous human body, and isolation technology can relatively seal these environments.
Therefore, the pharmaceutical machinery isolation technology has two characteristics of cleanliness and safety, which makes up for the many regrets caused by the production of large-scale drugs. It can be said that the isolation technology is a trend of pharmaceutical machinery development in the future.
Why is isolation technology a trend in the future development of pharmaceutical machinery? It is well known that the production of pharmaceuticals is controlled by two parts of insoluble particles and microorganisms such as dust. Among them, the control of insoluble particulate pollution is one of the most difficult indicators to control in aseptic production. The source of insoluble particulates has four aspects in the production process, namely utility system, operating system, process material system and equipment or appliance system. .
In order to ensure the control indicators of insoluble particulate pollution, it is necessary to strictly control all aspects, of which the operating system involves human factors. General clean room Under normal circumstances, the biggest source of pollution in the room is still human. Often more concerned about the amount of bacteria in the human body, the microorganisms in the indoor air are mainly attached to the particles and droplets sprayed from the nasal cavity and mouth of the human body. Therefore, people are the main factor in the amount of dust generated and the amount of bacteria emitted, so the number of people entering the clean room should be strictly controlled. In the appendix to the new European GMP amendment, it is still considered that “the use of isolation techniques that limit the movement of personnel in production areas can effectively reduce the risk of bacterial contamination in the production of sterile pharmaceutical products.â€
In addition, while considering the pollution in the clean area, we must also consider: (1) The fresh air volume of the clean room must be 40m3/h per person. If more people enter, the air conditioning system will become larger and the power will be It will be wasted; (2) At present, the domestic clean system verification is still limited to the static process, and there is still a distance from the cGMP requirements dynamic process. The main factor of the dynamic process is the personnel dynamics. It can be seen that the key to the clean production of pharmaceuticals is humans, so that the process of pharmaceutical machinery is in great need of isolation or unmanned development.
There is now a trend to reduce operator exposure limits (from 10μg/m3 to less than 1μg/m3) in pharmaceutical production. The ideal assembly line should be a closed system with on-site (in-place) cleaning or field cleaning. Direct exposure of the operator during the cleaning and maintenance process can be avoided. The root of this statement is the relative isolation between people and the production of drugs.
In addition, the isolation technology of the pharmaceutical process also plays a safety role while ensuring the production process. The implementation of pharmaceutical machinery isolation can use isolation to achieve human protection. Because the pharmaceutical process is like the chemical industry, its production process involves toxic and harmful, susceptibility and other dangerous human body, and isolation technology can relatively seal these environments.
Therefore, the pharmaceutical machinery isolation technology has two characteristics of cleanliness and safety, which makes up for the many regrets caused by the production of large-scale drugs. It can be said that the isolation technology is a trend of pharmaceutical machinery development in the future.
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